Borage seed oil as an anti-irritant in compositions containing hydroxy acids or retinoids

ABSTRACT

Compositions containing hydroxy acids and/or retinoids and further containing borage seed oil as an anti-irritant. Borage seed oil was found to be uniquely effective (when compared to gamma-linolenic acid, or other anti-irritants containing gamma-linolenic acid or other known anti-irritants) in reducing the irritation caused by hydroxy acids and/or retinoids.

This application is a continuation of 08/706,009, Aug. 30, 1996, nowU.S. Pat. No. 5,690,947.

FIELD OF THE INVENTION

The present invention relates to the use of borage seed oil in acomposition and a method for reducing or eliminating skin irritationinduced by hydroxy acids or retinoids.

BACKGROUND OF THE INVENTION

Hydroxy acids (HAs) and retinoids have been proven to deliver cosmeticbenefits, such as improvement in the appearance of photodamaged ornaturally aged skin, skin lightening, treatment of age spots, etc.Unfortunately, their use at high concentrations may occasionally beassociated with skin irritation, e.g. skin redness and stingingsensation upon application. The irritation can be ameliorated bylowering the amount of an active ingredient in the composition or byreducing the active's penetration through the skin. A serious drawbackof both approaches is that the efficacy is impaired. The HA relatedirritation can be reduced by raising the composition's pH but thismethod yields reduced efficacy through a decreased HA penetrationthrough the skin. It is desirable to reduce or eliminate the irritationpotential of HAs and/or retinoids while maintaining their efficacy.

European Patent Application 0631722 (Johnson & Johnson) discloses theuse of glycolic acid to reduce irritation of the skin by retinol. U.S.Pat. No. 5,252,604 (Nagy et al.) teaches the use of tocopherols forretinoic acid induced irritation. U.S. Pat. No. 5,516,793 (Duffy)discloses the use of ascorbic acid to ameliorate the irritation causedby various topical ingredients, including HAs and retinoids.

U.S. Pat. No. 5,476,661 (Pillai et al.) discloses cosmetic compositionscontaining 25-hydroxycalciferol and a lipid ingredient. Numerousoptional ingredients are listed among which are mentioned HAs and/orretinoids and unsaturated fatty acids, such as gamma linolenic acid(GLA). Pillai et al. do not address the problem of skin irritation, donot teach the use of any agent for reducing skin irritation and do notteach the use of borage seed oil.

European Patent Application 0416855 (Efamol) discloses treatment of skindamage due to radiotherapy with gamma linolenic acid (GLA) and alsoteaches a variety of suitable plant sources of GLA, including Boragespecies. PCT application WO 90/07331 (Went) teaches treatment ofinflammation arising from arthritis or headache by topical applicationof GLA; borage seed is taught as a suitable source. European PatentApplication 0173478 (Efamol) discloses treatment of inflammatory skindisorders with compositions containing GLA and glucocorticoids; boragespecies such as Borago officinalis is mentioned as a rich source of GLA.French patent 2,704,390 (Boiron) discloses an oral supplement containingborage seed oil to provide anti-aging benefits to skin. French patent2,604,624 (Parfums Rochas) discloses skin care compositions containingpolyunsaturated carboxylic acids, such as GLA; borage is said to be richin GLA. U.S. Pat. No. 5,445,822 (Bracco) discloses cosmetic compositionscontaining polyunsaturated acids such as GLA.

Great Britain Patent 2,271,928 (Laing) discloses the use of boragefamily plant extracts for alleviation of skin disorders and irritations.

Tollesson et al., "Transepidermal Water Loss and Water Content in theStratum Corneum in Infantile Sebhorroeic Dermatitis", Acta Derm Venereol(Sweden), February 1993, 73 (1), p. 18-20, disclose the use of topicallyapplied borage oil for treatment of sebhorroeic dermatitis.

Bahmer et al., "Treatment of Atopic Dermatitis with Borage Seed Oil(Glandol)--A Time Series Analytic Study", Kinderarztl Prax (Germany),October 1992, 60 (7), p. 199-202, disclose the use of borage oil for thetreatment of atopic dermatitis.

The art discussed above does not teach any compositions containingborage seed oil in combination with HAs and/or retinoids. The art doesnot teach the use of GLA or borage seed oil to reduce irritationassociated with the use of HAs and/or retinoids. Furthermore, it wasfound as part of the present invention that among GLA containing plantsources borage seed oil was particularly effective at amelioratingirritation induced by HAs or retinoids and that this effect could not beattributed merely to the presence of GLA in the borage seed oil.

SUMMARY OF THE INVENTION

The present invention includes, in part, a composition containing acosmetic benefit ingredient selected from the group consisting ofhydroxy acids and certain retinoids and further containing borage seedoil in an amount effective to ameliorate the irritation induced by theactive agent.

The invention also includes a method for reducing irritation induced bythe topical application of a composition containing HAs or retinoids,the method comprising topically applying borage seed oil in an amounteffective to reduce irritation induced by the composition. According tothe inventive method, borage seed oil may be co-present with HAs and/orretinoids in the same composition, or borage seed oil may be appliedfrom a separate composition.

According to the present invention, by virtue of topical application ofborage seed oil, the irritation induced by the topical application ofHAs and/or retinoids is reduced or eliminated. It has been found as partof the present invention that not all known anti-irritants, even thosethat contain GLA, ameliorate HA/retinoid induced irritation.

DETAILED DESCRIPTION OF THE INVENTION

Borage seed oil is an essential ingredient of the inventivecompositions.

Borage seed oil is obtained from the seeds of borage plant, also knownas Borago officinalis L. (Boraginaceae), which is an herbaceous annualplant, native to Europe, Asia Minor and North Africa, naturalized in theUnited States. The seed oil contains: gamma-linoleic acid (GLA), ˜24%,sterols (e.g., campestrol and sitosterol), tocopherols, linoleic acid(˜38%), oleic acid (14.5-23%), palmitic (˜4.7%), amabiline, etc. SeeWhipkey, A., J. E. Simon and J. Janick, "In Vivo and In Vitro LipidAccumulation in Borago officinalis L.", JAOCS, 65 (6), 979-984 (1988);and Leung, A. Y. and S. Foster, "Encyclopedia of Common NaturalIngredients Used in Food, Drugs and Cosmetics", 2nd ed., John Wiley &Sons, Inc., New York (1996).

Borage seed oil is employed according to the present invention to reduceor eliminate the skin irritation induced by hydroxy acids and/orretinoids.

The amount of borage seed oil in the inventive compositions rangesgenerally from about 0.05% to about 10% by weight of the composition,preferably from about 0.1% to about 5%, most preferably from about 0.5%to about 2%.

Hydroxyacids enhance proliferation and increase ceramide biosynthesis inkeratinocytes, increase epidermal thickness, and increase desquamationof normal skin resulting in smoother, younger looking skin.

The hydroxy acid can be chosen from α-hydroxy acids, β-hydroxyacids(e.g. salicylic acid), other hydroxycarboxylic acids (e.g.,dihydroxycarboxylic acid, hydroxydicarboxylic, hydroxytricarboxylic) andmixtures thereof or combination of their stereoisomers (DL, D or L).

Preferably the hydroxy acid (ii) is chosen from α-hydroxy acids havingthe general structure (13): ##STR1## where M is H-- or CH₃ (C_(f)H_(g))_(h) --, f is an integer of from 1 to 27,

g is an integer of from 2 to 54, and

h is 0or 1.

Even more preferably the hydroxy acid is chosen from lactic acid,2-hydroxyoctanoic acid, hydroxylauric lactic acid, glycolic acid, andmixtures thereof. When stereo isomers exist, L-isomer is most preferred.

The keto acids can be chosen from α-keto acids, β-keto acids andmixtures thereof.

A particularly preferred α-keto acid is 2-keto octanoic acid.

It is to be understood that depending on the pH of the composition, thehydroxy acid may be present as a salt, e.g. ammonium or potassium orsodium salt.

Although the inventive compositions may have any pH in the general rangeof 2.5 to 10, the inventive compositions are particularly useful whenthey are at an acidic pH (especially if they contain a hydroxy acid),most preferably at a pH of 3-4, because such compositions areparticularly irritating.

Retinoids enhance keratinocyte proliferation in vitro, increaseepidermal thickness and increase collagen synthesis by dermalfibroblasts. This results in protection from sun damage and smoothing ofwrinkled skin. The term "retinoids" as used herein includes retinoicacid, retinol, retinal and C₂ -C₅ retinyl esters. Included in the term"retinoic acid"are 13-cis retinoic acid and all-trans retinoic acid.

The term "retinol" includes the following isomers of retinol:all-trans-retinol, 13-cis-retinol, 11-cis-retinol, 9-cis-retinol,3,4-didehydro-retinol. Preferred isomers are all-trans-retinol,13-cis-retinol, 3,4-didehydro-retinol, 9-cis-retinol. Most preferred isall-trans-retinol, due to its wide commercial availability.

Retinyl ester is an ester of retinol. The term "retinol" has beendefined above. Retinyl esters suitable for use in the present inventionare C₂ -C₅ esters of retinol, preferably C₂ and C₃ esters, and mostpreferably C₂ ester because it is more commonly available. Retinylesters included in the invention are also known as: retinyl acetate,retinyl propionate, retinyl butyrate, and retinyl pentanolate.

A particular advantage of the inventive compositions is that higheramounts of hydroxy acids or retinoids may be employed without causingskin irritation. Preferably the amount of the hydroxy acid componentpresent in the composition according to the invention is from 0.01 to20%, more preferably from 2 to 12% and most preferably from 4 to 12% byweight.

A retinoid may be present in the inventive compositions in an amount 33to 330,000 IU per gram of the composition, preferably 330 to 16,500 IU,most preferably 1,650 to 6,600 IU. Again, a higher amount of a retinoidmay be employed in the inventive compositions without causing skinirritation, due to the co-presence of borage seed oil.

Most preferred inventive compositions containing borage seed oilanti-irritant include retinol and/or glycolic acid and/or lactic acidbecause these ingredients have been found to cause irritation yet theywere found to be particularly efficacious at delivering cosmeticbenefits.

The skin treatment composition of the invention also includes acosmetically acceptable vehicle or a carrier which is inert, usually aningredient present in the highest amounts, and functioning to deliveractive or performance ingredients. Vehicles other than water can includeliquid or solid emollients, solvents, humectants, thickeners andpowders. An especially preferred nonaqueous carrier is a polydimethylsiloxane and/or a polydimethyl phenyl siloxane. Silicones of thisinvention may be those with viscosities ranging anywhere from about 10to 10,000,000 centistokes at 25° C. Especially desirable are mixtures oflow and high viscosity silicones. These silicones are available from theGeneral Electric Company under trademarks Vicasil, SE and SF and fromthe Dow Corning Company under the 200 and 550 Series. Amounts ofsilicone which can be utilized in the compositions of this inventionrange anywhere from 5 to 95%, preferably from 25 to 90% by weight of thecomposition. The amount of vehicle may range from about 2 to about 99 wt%, preferably from about 50 to about 99%, most preferably from about 80to 99%, by weight of the total composition.

Optional Skin Benefit Materials and Cosmetic Adjuncts

Various types of active ingredients may be present in cosmeticcompositions of the present invention. Actives are defined as skinbenefit agents other than emollients and other than ingredients thatmerely improve the physical characteristics of the composition. Althoughnot limited to this category, general examples include anti-wrinklecompounds and sunscreens and tanning agents.

Sunscreens include those materials commonly employed to blockultraviolet light. Illustrative compounds are titanium dioxide, thederivatives of PABA, cinnamate and salicylate. For example, octylmethoxycinnamate and 2-hydroxy-4-methoxy benzophenone (also known asoxybenzone) can be used. Octyl methoxycinnamate and 2-hydroxy-4-methoxybenzophenone are commercially available under the trademarks, Parsol MCXand Benzophenone-3, respectively. The exact amount of sunscreen employedin the emulsions can vary depending upon the degree of protectiondesired from the sun's UV radiation.

Another category of functional ingredients within the cosmeticcompositions of the present invention are thickeners. A thickener willusually be present in amounts anywhere from 0.1 to 20% by weight,preferably from about 0.5% to 10% by weight of the composition.Exemplary thickeners are cross-linked polyacrylate materials availableunder the trademark Carbopol from the B.F. Goodrich Company. Gums may beemployed such as xanthan, carrageenan, gelatin, karaya, pectin andlocust beans gum. Under certain circumstances the thickening functionmay be accomplished by a material also serving as a silicone oremollient. For instance, silicone gums in excess of 10 centistokes andesters such as glycerol stearate have dual functionality.

Powders may be incorporated into the cosmetic composition of theinvention. These powders include chalk, talc, Fullers earth, kaolin,starch, smectite clays, chemically modified magnesium aluminum silicate,organically modified montmorillonite clay, hydrated aluminum silicate,fumed silica, aluminum starch octenyl succinate and mixtures thereof.

Other adjunct minor components may also be incorporated into thecosmetic compositions. These ingredients may include coloring agents,opacifiers and perfumes. Amounts of these materials may range anywherefrom 0.001% up to 20% by weight of the composition.

Use of the Composition

The composition according to the invention is intended primarily as aproduct for topical application to human skin, especially as an agentfor conditioning and smoothening the skin, and preventing or reducingthe appearance of wrinkled or aged skin.

In use, a small quantity of the composition, for example from 1 to 5 ml,is applied to exposed areas of the skin, from a suitable container orapplicator and, if necessary, it is then spread over and/or rubbed intothe skin using the hand or fingers or a suitable device.

According to the present inventive method, the skin irritation inducedby the active ingredient is reduced or eliminated by topical applicationof borage seed oil. The borage seed oil may be co-present with theactive, or it may be applied to the skin separately from the active.

Product Form and Packaging

The topical skin treatment composition of the invention can beformulated as a lotion, a fluid cream, a cream or a gel. The compositioncan be packaged in a suitable container to suit its viscosity andintended use by the consumer. For example, a lotion or fluid cream canbe packaged in a bottle or a roll-ball applicator, or a capsule, or apropellant-driven aerosol device or a container fitted with a pumpsuitable for finger operation. When the composition is a cream, it cansimply be stored in a non-deformable bottle or squeeze container, suchas a tube or a lidded jar.

The invention accordingly also provides a closed container containing acosmetically acceptable composition as herein defined.

The borage seed oil may be packaged separately from the compositioncontaining HAs and/or retinoids.

The following specific examples further illustrate the invention, butthe invention is not limited thereto. Borage seed oil employed in theexamples was obtained from Canamino, Inc. (Northport, N.Y.).

EXAMPLE 1

Seventeen subjects were tested according to Irritation Test Methoddescribed below.

Irritation Test Method

Four Exposure Patch Test: The objective was to compare the level ofirritation produced by various test materials after repeated patchapplications. The test materials were held in contact with the skinunder occlusive conditions. The outer upper arm of the panelist wasdesignated as the area of application. Bandage type dressing (Scanpor®tape) was used to hold the patches (25 mm Hill Top® Chamber fitted with18 mm diameter disc of Webril® padding) into place. Both upper arms ofthe panelist were used. Patches were applied in a balanced random order.

Patches were applied at 9:00 o'clock Monday morning and removed at 9:00o'clock Tuesday morning (24 hour exposure). A new set of patches wasapplied at 3:00 o'clock Tuesday afternoon and removed Wednesday morningat 9:00 o'clock (18 hour exposure). A third set of patches was appliedat 3:00 o'clock Wednesday afternoon and removed Thursday morning at 9:00o'clock (18 hour exposure). A final set of patches was applied at 3:00o'clock Thursday afternoon and removed Friday morning at 9:00 o'clock(18 hour exposure).

Each time the patches were removed, the sites were rinsed with warmwater and patted dry The test sites were then marked with a surgicalskin marking pen to ensure location for grading and subsequent patchapplications. Test sites were evaluated at 3:00 p.m. on Tuesday,Wednesday, Thursday and Friday of the study, prior to re-patching.

Skin irritation such as moderate redness, dryness, and/or itching of thetest site is expected. Swelling of the test sites is possible. If anytest has moderate redness or any swelling at evaluation, that particulartest site should not be repatched.

The test sites on each arm were visually ranked by two trained examinersunder consistent lighting. The test sites were ranked in order ofseverity. The examiner ranking responses at the first evaluation periodcontinued ranking the sites each day throughout the study.

In ranking the reactions, the site with the most severe response wasgiven the lowest score. The site with the second most severe responsewas given the second lowest score, etc. There was no forced ranking. Iftwo or more sites had no response or the same response (no differencebetween sites), an average of the ranks was assigned. If a site has beendiscontinued, due to degree of irritation the site retained the rank itreceived at the time dosing was discontinued.

Statistical Analysis

The ranking results from the patch treatments were statisticallycompared by nonparametric statistical methods. The test materialscontaining the anti-irritants were compared to the corresponding controlcontaining only hydroxy acid and/or retinoid, using Friedman's Rank Sum.Treatments were compared to the Formula 2 (control) at each evaluationpoint using Friedman's analysis with the panelist acting as a block(i.e., each panelist was tested with each test treatment). p-value of≦0.1 was considered statistically significant.

An emulsion base was prepared having the following formula.

    ______________________________________                                        EMULSION BASE FORMULA                                                         FULL CHEMICAL NAME OR                                                                         TRADE NAME AND %                                              CFTA NAME       ACTIVE AS RECEIVED                                                                             WT. %                                        ______________________________________                                        water, DI                        46.54                                        disodium EDTA   Sequesterene Na2 0.05                                         magnesium aluminum silicate                                                                   Veegum Ultra     0.6                                          methyl paraben  Methyl Paraben   0.15                                         simethicone     DC Antifoam Emulsion                                                                           0.01                                         butylene glycol 1,3                                                                           Butylene Glycol 1,3                                                                            3.0                                          hydroxyethylcellulose                                                                         Natrosol 250HHR  0.5                                          glycerine, USP  Glycerine USP    2.0                                          xanthan gum     Keltrol 1000     0.2                                          triethanolamine Triethanolamine 99(%)                                                                          1.2                                          stearic acid    Pristerene 4911  3.0                                          propyl paraben NF                                                                             Propylparaben NF 0.1                                          glyceryl hydrostearate                                                                        Naturechem GMHS  1.5                                          stearyl alcohol Lanette 18DEO    1.5                                          isostearyl palmitate                                                                          Protachem ISP    6.0                                          C12-15 alcohols octanoate                                                                     Hetester FAO     3.0                                          dimethicone     Silicone Fluid 200 (50 cts)                                                                    1.0                                          cholesterol NF  Cholesterol NF   0.5                                          sorbitan stearate                                                                             Sorbitan Stearate                                                                              1.0                                          butylated hydroxytoluene                                                                      Embanox BHT      0.05                                         tocopheryl acetate                                                                            Vitamin E Acetate                                                                              0.1                                          PEG-100 stearate                                                                              MYRJ 59          2.0                                          water, DI                        q.s.                                                                          to 99.80                                     alpha-bisabolol Alpha-bisabolol  0.2                                          pH                               7-8                                          ______________________________________                                    

Composition 1-5 containing ingredients as indicated in Table 1 weretested using the Irritation Test Method. The results that were obtainedare summarized in Table 1. The higher the Sum of Ranks, the less severethe irritation.

                  TABLE 1                                                         ______________________________________                                        Irritation Test Results                                                                                   SUM OF                                            COM-                        RANKS                                             POSITION                                                                              INGREDIENTS         (DAY 4)  % GLA                                    ______________________________________                                        1       Base Formula        68.5.sup.a                                        2       Control: Base Formula + 8%                                                                        46.5                                                      Glycolic Acid and 0.075% Retinol                                      3       Composition #2 + 0.5% Borage                                                                      69.5.sup.a                                                                             0.115                                            Seed Oil                                                              4       Composition #2 + 3% Black Currant                                                                 58.0     0.51                                             Seed Oil                                                              5       Composition #2 + 1% Sambucus                                                                      44.5                                              ______________________________________                                         .sup.a Significantly less irritating than composition #2.                

It can be seen from the results in Table 1 that after four exposures, 8%glycolic acid with 0.075% retinol (#2) was significantly more irritatingthan Base formula #1. 8% glycolic acid and 0.075% retinol was alsosignificantly more irritating than the same composition containingBorage seed oil (#3).

By contrast, 1% Sambucus (#5) or 3% Black Currant Seed Oil (#4) did notsignificantly reduce the irritation.

Sambucus and Black currant seed oil are known anti-irritants. Blackcurrant seed oil also contains 17% GLA. However, neither agent waseffective in reducing alpha hydroxy acid/retinol induced irritation.

The art teaches that the formulation with higher total % GLA would beexpected to be less irritating. In this case, the black currant seed oilformulation would have been expected to be less irritating than theborage seed oil formulation. Surprisingly, we found that the borage seedoil formulation which contained a significantly lower concentration ofGLA was less irritating than the black currant seed oil formulation,although the black currant seed oil formulation contained five timesmore GLA than borage seed oil.

COMPARATIVE EXAMPLE 2

Compositions 1, 2 and 6-9 containing ingredients as indicated in Table 2were tested using the Irritation Test Method described in Example 1.Seventeen subjects were tested. The results that were obtained aresummarized in Table 2. The higher the sum of ranks, the less is theirritation.

                  TABLE 2                                                         ______________________________________                                        Irritation Test Results                                                                                      SUM OF                                                                        RANKS                                          COMPOSITION #                                                                              INGREDIENTS       (DAY 4)                                        ______________________________________                                        1            Base Formula      74.5.sup.a                                     2            Base Formula + 8% Glycolic +                                                                    61.5                                                        0.075% Retinol                                                   6            Composition #2 + 1% Green                                                                       51.0                                                        Tea                                                              7            Composition #2 + 0.1% K2                                                                        54.5                                                        Glycyrrohetinic Acid                                             8            Composition #2 + 3% Quench                                                                      55.5                                                        T*                                                               9            Composition #2 + 3% Polyol                                                                      57.0                                                        Prepolymer-2**                                                   ______________________________________                                         .sup.a Statistically less irritating than Composition #2.                     *An antiirritant from Centerchem (containing water, butylene glycol, kola     bean extract, guarana extract, and mate extract).                             **An antiirritant from Penederm, Inc. (CFTA name PPG12/SMDI).            

It can be seen from the results in Table 2 that none of theanti-irritants tested (none contained GLA) were able to significantlyreduce the irritation induced by composition #2 (containing 8% GlycolicAcid and 0.075% Retinol).

EXAMPLE 3

Composition 10-13 containing ingredients as indicated in Table 3 weretested using the Irritation Method described in Example 1. Composition10 was similar to composition 1 in Example 1, except that composition 10additionally contained 0.5% sodium stearyl lactylate, 0.1% retinylpalmitate and 0.1% hydroxy caprylic acid ("Base Formula A"). The higherthe Sum of Ranks, the less severe the irritation.

                  TABLE 3                                                         ______________________________________                                        Irritation Test Results                                                                               SUM OF                                                COM-                    RANKS    % GLA IN                                     POSITION #                                                                             INGREDIENT     (DAY 4)  COMPOSITION                                  ______________________________________                                        10       Base Formula A 75.5.sup.a                                                                             0                                            11       Base Formula A + 8%                                                                          48.5     0                                                     Glycolic Acid                                                        12       Base Formula A + 8%                                                                          44.5     0.125                                                 Glycolic Acid + 0.125%                                                        GLA                                                                  13       Base Formula A + 8%                                                                          61.0     0.115                                                 Glycolic Acid + 0.5%                                                          Borage Seed oil                                                      ______________________________________                                         .sup.a Statistically significant compared to composition #11.            

It be seen can from the results in Table 3, that the addition of 8%glycolic acid (composition #11) significantly increased the irritation.Upon further addition of borage seed oil (composition #13), theirritation was directionally reduced. By contrast, a composition whichcontained a similar amount of GLA as composition #13, but not fromborage seed oil, did not at all reduce the irritation induced byglycolic acid. This again demonstrsates thjat borage seed oil efficacyat reducing HA irritation is unique and cannot to the presence of GLA.

EXAMPLE 4

Twenty-one (21) subjects were tested according to the Irritation TestMethod described in example 1.

Compositions 11, 13 and 14 containing ingredients as indicated in Table4 were tested using the Irritation Test Method. The results that wereobtained are summarized in Table 4. The higher the Sum of Ranks, theless severe the irritation.

                  TABLE 4                                                         ______________________________________                                        Irritation Test Results                                                                               SUM OF RANKS                                          COMPOSITION                                                                              INGREDIENTS  (DAY 4)      % GLA                                    ______________________________________                                        11         Base Formula A +                                                                           52.0                                                             8% Glycolic Acid                                                   13         Composition #11 +                                                                          65.5         0.115                                               0.5% Borage Seed                                                              Oil                                                                14         Composition #11 +                                                                          78.0.sup.a   0.23                                                1.0% Borage Seed                                                              Oil                                                                ______________________________________                                         .sup.a Significantly less irritating than Composition #11.               

It can be seen from the results in Table 4 that after four exposures, 8%glycolic acid (#11) was significantly more irritating than the samecomposition containing 1% Borage seed oil (#14). Upon addition of 0.5%Borage seed oil (#14), irritation was directionally less as waspreviously shown in Example 3.

EXAMPLE 5

A typical oil-in-water emulsion within the scope of the invention is asfollows:

    ______________________________________                                        chemical name          wt. %                                                  ______________________________________                                        propylene glycol       1                                                      glycerin               1                                                      hydroxyethylcellulose  0.5                                                    magnesium aluminum silicate                                                                          0.5                                                    imidazolidinyl urea    0.5                                                    tetrasodium EDTA       0.05                                                   petrolatum             2                                                      isopropyl palmitate    5                                                      dimethicone            0.5                                                    cholesterol            0.5                                                    cetyl alcohol          0.5                                                    isostearic acid        3                                                      retinyl palmitate      0.1                                                    peg-40 stearate        1                                                      peg-100 stearate       1                                                      sorbitan stearate      1                                                      borage seed oil        0.5                                                    glycolic acid          7                                                      ammonium hydroxide     to pH 4.0                                              water DI               qs to 100%                                             ______________________________________                                    

EXAMPLE 6

Another typical oil-in-water emulsion within the scope of the inventionis as follows:

    ______________________________________                                        chemical name          wt. %                                                  ______________________________________                                        propylene glycol       1                                                      hydroxyethylcellulose  0.5                                                    magnesium aluminum silicate                                                                          0.5                                                    imidazolidinyl urea    0.2                                                    petrolatum             2                                                      isopropyl palmitate    5                                                      dimethicone            0.5                                                    cholesterol            0.5                                                    stearic acid           3                                                      isostearic acid        1.5                                                    glycerol stearate      1.5                                                    peg-40 stearate        1                                                      peg-100 stearate       1                                                      sorbitan stearate      1                                                      cetyl alcohol          0.5                                                    borage seed oil        1                                                      glycolic acid          10                                                     ammonium hydroxide     to pH 3.8                                              water DI               qs to 100%                                             ______________________________________                                    

EXAMPLE 7

A typical water-in-oil dispersion within the scope of the invention isas follows:

    ______________________________________                                        chemical name            wt. %                                                ______________________________________                                        isostearyl neopentanoate 20                                                   peg-8 caprylic/capric glycerides                                                                       16                                                   cetyl octanoate          17                                                   polyglyceryl-6 dioleate  15                                                   cyclomethicone           20                                                   glyceryl isostearate     0.5                                                  isostearic acid          0.5                                                  ceramide III             0.1                                                  ppg-5-cetheth-20         3                                                    L-lactic acid/potassium lactate                                                                        6                                                    hydroxycaprylic acid     0.1                                                  water DI                 1.3                                                  borage seed oil          0.5                                                  ______________________________________                                    

EXAMPLE 8

The following oil-in-water emulsion within the scope of the invention isprepared:

    ______________________________________                                        chemical name         wt. %                                                   ______________________________________                                        glycerin              1                                                       tetrasodium EDTA      0.1                                                     cetyl alcohol         1                                                       stearyl alcohol       1                                                       mineral oil           5                                                       dimethicone           1                                                       cyclomethicone        0.5                                                     dimethiconol          0.2                                                     polyquaternium 37     2                                                       steareth-21           1                                                       steareth-2            0.5                                                     salicylic acid        2                                                       borage seed oil       0.5                                                     triethanolamine       to pH 3.0                                               water DI              qs to 100%                                              ______________________________________                                    

EXAMPLE 9

The following oil-in-water emulsion within the scope of the invention isprepared:

    ______________________________________                                        chemical name         wt. %                                                   ______________________________________                                        xanthan gum           0.2                                                     disodium EDTA         0.1                                                     sodium PCA            0.5                                                     diazodinyl urea       0.3                                                     titanium dioxide      1                                                       stearic acid          3                                                       cyclomethicone        0.3                                                     cetyl alcohol         0.5                                                     glyceryl stearate     0.5                                                     peg-100 stearate      0.5                                                     steareth-2            0.2                                                     lecithin              0.5                                                     tocopherol            0.2                                                     octyl methoxycinnamate                                                                              6                                                       borage seed oil       0.5                                                     glycolic acid         3                                                       malic acid            2                                                       lactic acid           2                                                       green tea extract     1                                                       triethanolamine       to pH 3.8                                               water DI              qs to 100%                                              ______________________________________                                    

EXAMPLE 10

The following oil-in-water emulsion within the scope of the invention isprepared:

    ______________________________________                                        chemical name            wt. %                                                ______________________________________                                        all-trans retinoic acid  0.05                                                 light mineral oil        10                                                   stearoxytrimethylsilane and stearyl alcohol                                                            5                                                    dimethicone              2                                                    stearyl stearate         10                                                   quaternium-15            3                                                    peg-22 dodecyl glycol copolymer                                                                        1                                                    borage seed oil          1                                                    sorbitol                 0.5                                                  methyl paraben           0.2                                                  disodium EDTA            0.1                                                  butylated hydroxytoluene 0.1                                                  water DI                 qs to 100%                                           ______________________________________                                    

EXAMPLE 11

The following oil-in-water emulsion within the scope of the invention isprepared:

    ______________________________________                                        chemical name          wt. %                                                  ______________________________________                                        squalane               20                                                     macadamia oil          5                                                      pentaerythritol tetraoctanoate                                                                       15                                                     petrolatum             5                                                      glyceryl stearate      3                                                      tocopherol acetate     0.5                                                    butylated hydroxytoluene                                                                             0.05                                                   methyl paraben         0.15                                                   propyl paraben         0.15                                                   retinol                0.1                                                    borage seed oil        0.25                                                   sodium citrate         1                                                      ascorbic acid          1                                                      butylene glycol        2                                                      glycerol               2                                                      bentone clay           0.2                                                    disodium EDTA          0.05                                                   water DI               qs to 100%                                             ______________________________________                                    

EXAMPLE 12

The following oil-in-water emulsion within the scope of the invention isprepared:

    ______________________________________                                        chemical name          wt. %                                                  ______________________________________                                        glycerin               1.5                                                    butylene glycol        2.2                                                    disodium EDTA          0.05                                                   methyl paraben         0.1                                                    xanthan gum            0.2                                                    magnesium aluminum silica                                                                            0.3                                                    hydroxyethyl cellulose 0.2                                                    glyceryl monohydroxystearate                                                                         2                                                      stearyl alcohol        1.5                                                    cholesterol            0.5                                                    sorbitan stearate      1                                                      peg-100 stearate       2                                                      sodium stearyl lactylate                                                                             0.4                                                    propyl paraben         0.1                                                    borage seed oil        4                                                      black currant seed oil 5                                                      evening primerose oil  3                                                      isostearyl palmitate   18                                                     butylated hydroxystearate                                                                            0.05                                                   retinoi                0.075                                                  retinyl palmitate      0.06                                                   tocopherol acetate     0.1                                                    alpha bisabolol        0.2                                                    glycolic acid          8                                                      potassium hydroxide    to pH 3.8                                              water DI               qs to 100%                                             ______________________________________                                    

It should be understood that the specific forms of the invention hereinillustrated and described are intended to be representative only.Changes, including but not limited to those suggested in thisspecification, may be made in the illustrated embodiments withoutdeparting from the clear teachings of the disclosure. Accordingly,reference should be made to the following appended claims in determiningthe full scope of the invention.

What is claimed is:
 1. A method for reducing irritation induced by thetopical application of a composition containing an α-hydroxyacid or aretinoid selected from the group consisting of retinol, retinoic acid,retinal, and C₂ -C₅ retinyl ester and mixtures thereof, the methodcomprising topically applying borage seed oil in an amount effective toreduce irritation induced by the composition.